The 503B Quality Assurance Associate II is responsible for review of batch records, qualifications, and protocols associated with 503B in accordance with applicable SOPs. The purpose of QA review is to ensure the document, product, or process under assessment is compliant with all TRC, customer, and regulatory agency requirements.

　　Responsibilities:

　　Copy and scan batch records and QMS documentation

　　Batch record review for completeness, accuracy, and compliance to TRC standards and coordinate required corrections

　　Verification of critical processing steps (dispensing, compounding, sterile transfer, visual inspection, etc.)

　　Elevate deviations, IRs, OOS and other issues impacting quality to Direct Supervisor or other applicable parties

　　Issue product Certificate of Analysis and upload batch trend data

　　Create and revise Quality documents associated with 503B

　　Track and trend the batch record review process; identify and initiate improvements to process.

　　Perform Product Complaint batch record review

　　Maintain a professional team-oriented working relationship with fellow employees

　　Follow written and verbal procedures as directed by Supervisor

　　Follow TRC SOPs, safety and health guidelines and cGMP guidelines

　　Qualifications:

　　Minimum of Associates degree with 1 year of relevant experience, Bachelors degree, or 3 years relevant experience

　　Proficient with current word processing, spreadsheets, and database software

　　A high level of integrity and attention to detail

　　Ability to work independently as well as to participate in and contribute to a team-oriented work environment by developing positive working relationships within Quality and between other departments

　　Ability to handle and establish multiple priorities and meet expectations with minimal supervision

　　Strong written and oral communication skills

　　Qualifications

　　Minimum of Associates degree with 1 year of relevant experience, Bachelors degree, or 3 years relevant experience

　　Proficient with current word processing, spreadsheets, and database software

　　A high level of integrity and attention to detail

　　Ability to work independently as well as to participate in and contribute to a team-oriented work environment by developing positive working relationships within Quality and between other departments

　　Ability to handle and establish multiple priorities and meet expectations with minimal supervision

　　Strong written and oral communication skills